Wednesday, September 30, 2009

In a column published yesterday on the Bottom Line's Daily Health News, Dr. Steven Marcus, executive director of the New Jersey Poison Information & Education System, apparently accuses the tobacco companies of producing and marketing electronic cigarettes as a ploy to hook kids and deceive smokers into thinking that these devices are a safe alternative to smoking.

Dr. Marcus either writes or is attributed as arguing that: "In their ever-diabolical efforts to sell their dangerous wares, cigarette manufacturers and marketers have created a new smoke screen... electronic cigarettes, which are touted as a safe alternative to smoking. These are small, battery-powered, refillable devices that resemble traditional cigarettes but don’t actually burn tobacco. While the product is said to contain "only" pure nicotine (which is unsafe), a recent FDA analysis indicates nicotine is not the only danger they present ... The new "fake cigarettes" supposedly contain just liquid nicotine -- but a recent FDA report found nitrosamines in half the samples from the two leading brands tested. Dr. Marcus made it a point to say that "you should not get nitrosamines unless you burn something" and that "these things are not supposed to burn." Nitrosamines are the key carcinogens in tobacco. So the question is, if there is nothing burning in e-cigarettes, then where do the nitrosamines come from?"

The Rest of the Story

There's just one problem with this health column.

It's false.

E-cigarettes are not produced and marketed by tobacco companies. Big Tobacco has nothing to do with them. In fact, these products are a great threat to Big Tobacco, because they are the first products on the market which actually pose a serious threat in terms of getting people to quit smoking.

Nicotine replacement products pose very little threat to tobacco companies because only about 8% of smokers who use these products are successful in quitting. But anecdotal reports suggest that electronic cigarettes are far more effective in achieving smoking cessation. So Dr. Marcus couldn't be further from the truth.

As far as where the nitrosamines come from, it's quite simple. The nicotine is extracted from tobacco, and trace levels of nitrosamines are present in the extracted nicotine. The same thing is true of nicotine gum and nicotine patches, which also contain trace levels of nitrosamines.

So while Dr. Marcus appears to challenge the assertion by e-cigarette distributors that these smoking alternatives do not contain tobacco, are not tobacco products, and do not involve the combustion of any material, the truth is that they contain no tobacco and they deliver nicotine through a vaporization, not a combustion process.

What Dr. Marcus doesn't reveal, in discouraging Garden State smokers to stay away from these dangerous and toxic e-cigarettes, is that traditional cigarettes contain up to 1400 times higher concentrations of nitrosamines (not to mention the other 40+ carcinogens) than e-cigarettes. He also doesn't mention the fact that nicotine replacement products also contain nitrosamines.

Shouldn't he, then, also be discouraging smokers from using NRT products? Shouldn't he also be warning smokers about the toxic and dangerous nature of nicotine gum, nicotine patches, and nicotine inhalers?

It's one thing to give out inappropriate health advice (suggesting that ex-smokers who have successfully quit using e-cigarettes discontinue using these devices is inappropriate, as most of them will return to cigarette smoking which will likely severely harm their health). But to give out inappropriate health advice based on completely untruthful information seems irresponsible as well.

Unfortunately, Dr. Marcus is not necessarily to blame. The FDA has given out misleading information to the public which likely led to Dr. Marcus' confusion. The FDA alarmed e-cigarette users by warning them about the carcinogens present in the product. But the FDA failed to provide the context for its pronouncement: it failed to mentiont that the levels of carcinogens were trace levels, that the same trace levels are found in nicotine replacement products, and that conventional cigarettes contain levels of these carcinogens that are orders of magnitude higher.

It's hard to blame physicians like Dr. Marcus when a reputable source of information like the FDA is disseminating misleading and deceptive information.

Or perhaps Dr. Marcus got his information from an anti-smoking group, like Smoke Free Wisconsin, which has still failed to correct its own false accusation against the tobacco companies: Smoke Free Wisconsin also claimed that Big Tobacco was marketing e-cigarettes as a ploy to hook kids, and continues to do so to this day, even though I have informed the group that it is wrong.

You will also see that numerous commenters have made it clear to Smoke Free Wisconsin that its claim is untruthful. But that has not stopped Smoke Free Wisconsin from continuing to advance its false claim. Apparently, the truth is threatening to this anti-smoking group because it ruins what would otherwise have been a juicy story. But since this is anti-tobacco, the truth doesn't matter anyway. It's all for a good cause.

Except that in this case, it's not for a good cause. The move to ban e-cigarettes from the market is a bad cause, because doing so would significantly harm the health of hundreds of thousands of ex-smokers who would be forced to return to cigarette smoking.

So in this case, we can't even claim that the lies are acceptable because they are for a good cause - helping improve the public's health. This is one case where we're lying and we're working to harm the public's health all at the same time.

One or the other would have been hard to take - but both together is hard for me to accept.

Tuesday, September 29, 2009

In a column published Sunday in the Chicago Tribune, Steve Chapman calls out the anti-smoking groups, federal spokespersons and politicians who have told the public that the flavored cigarette ban in the Family Smoking Prevention and Tobacco Control Act will break the cycle of addiction among youths and protect them from becoming prey to the tobacco industry's products.

Not so, argues Chapman. The flavored cigarette ban doesn't affect a single Big Tobacco product and affects less than 0.2% of the overall market, he notes, and therefore, it is deceptive, if not a lie, to tell the public that flavored cigarettes are a gateway to regular smoking (as the FDA Commissioner stated) and that the flavored cigarette ban will therefore break the cycle of addiction among youths.

Chapman argues: "At least since 1994, when seven tobacco executives testified before Congress that they didn't think cigarettes were addictive, the public has not put great trust in those who sell carcinogens for a living. What Americans may not realize is that they also shouldn't believe the people who are supposed to protect us from tobacco. When it comes to cigarettes, the federal government can blow smoke with the best of them."

"That became clear the other day, when the Food and Drug Administration announced it was prohibiting the sale of cigarettes with candy or fruit flavors. "These flavored cigarettes are a gateway for many children and young adults to become regular smokers," said Commissioner Margaret Hamburg. The ban, said Howard Koh, an assistant secretary at the Department of Health and Human Services, "will break that cycle [of addiction] for the more than 3,600 young people who start smoking daily."

"Sure it will. And I'm Megan Fox. When it comes to escorting kids into addiction, such cigarettes are more like the eye of a needle than a gateway. You would never know from the government's pronouncements that the nation's three major tobacco companies -- R.J. Reynolds, Philip Morris and Lorillard -- don't even make them. Notorious lines like Warm Winter Toffee and Winter Mocha Mint were removed from the market years ago. The only flavor the major producers use anymore is menthol, which happens to be one the FDA chose not to ban. Only a few small companies still offer the sort of flavors targeted by the government. According to one maker, Kretek International, these cigarettes account for less than two-tenths of 1 percent of all U.S. sales."

"When I asked an FDA spokesperson what portion of the cigarettes smoked by teens are flavored, she told me the agency doesn't know. So how does it know they serve as "a gateway for many children"? How does it know that banning them will have any effect on the number of new tobacco addicts? Actually, it doesn't. In any case, the number of kids using these products can't be very large. Michael Siegel, a physician and public health professor at Boston University, says that 87 percent of all high school smokers choose Marlboro, Camel or Newport, which don't come in tutti-frutti flavors. No surprise there. Siegel says that teenagers smoke because they want to seem older. But smoking something that tastes like bubble gum sends the opposite signal. Even when flavored cigarettes were more widely available, the great majority of adolescent smokers found them about as appealing as a Raffi concert."

The Rest of the Story

As I have long argued, the FDA tobacco law is a scam - designed to make it look like the health groups and federal government, along with Philip Morris, are doing something to protect kids from tobacco addiction when in fact the law does nothing of the sort. The flavored cigarette ban gets rid of a few minor brands which are hardly used by any youths, while exempting the one flavoring that is actually being used by millions of young people.

The rest of the story is that the health groups decided to sell out the health of African Americans by using menthol as a bargaining chip to secure Philip Morris' support for the legislation, which was deemed essential to the bill's passage. The menthol exemption was necessary because unlike the pineapple, banana, and cherry cigarettes which the law prohibits, people actually smoke menthol cigarettes so the financial interests of Big Tobacco depend on the continued sale of these products.

We wouldn't want to do anything to hurt Big Tobacco sales, would we? Especially when we now depend upon the continued sale of their products for fund health care for our nation's poor children. We wouldn't want to do anything that could actually make a significant dent in cigarette sales, would we? But as long as we can tell our constituents that we are winning the battle against Big Tobacco, we can collect our donations and fund ourselves, so what does it matter if we aren't actually protecting the public's health?

I'm glad that people are starting to take notice of this deception. Chapman's column will help educate the public about the truth behind the FDA tobacco law. Eventually, I believe it will be well-recognized that the FDA law surpasses the 1970 Cigarette Labeling and Advertising Act as the worst public health legislation ever enacted by Congress.

Thursday, September 24, 2009

As the FDA tobacco law's implementation commences, even supporters of the bill are beginning to realize that the law actually accomplishes nothing because of the severe loopholes that needed to be included in the bill to retain Philip Morris' support and get the bill passed. Most notable so far is the implementation of the law's ban on cigarette flavorings.

Touted by anti-smoking groups as "breaking the cycle of addiction" to tobacco products and keeping "another generation from falling prey to Big Tobacco’s deadly products," it became apparent yesterday that the new law actually doesn't remove a single Big Tobacco product from the market. Both Philip Morris and R.J. Reynolds confirmed that they have no products on the market which are covered by the cigarette flavoring ban.

Instead, the law forced the removal of some minor products made by small manufacturers that make up less than 0.2% of the overall cigarette market and which are hardly smoked by any youths. It is quite clear that the law will have zero impact on youth addiction to cigarettes and will reduce youth smoking by zero percent.

There are actually three major loopholes in the cigarette flavoring ban provision of the law.

First, the bill bans all the flavorings which are not actually used in the brands of cigarettes popular among youths (like pineapple, cherry, and chocolate), but exempts the one flavoring that is actually very popular among young people (menthol). While menthol cigarettes make up about 25% of the market, the cigarettes covered by the flavoring ban make up less than 0.2% of the market, and even less of the youth market.

Second, the bill only bans flavorings that are a "characterizing flavor" of the cigarette. Some cigarette manufacturers are arguing that their flavored cigarettes are allowable under the law because the flavoring being used in not a "characterizing flavor" of the product.

Third, the bill only bans flavorings in cigarettes, not in cigars or cigarillos. Even the New York Times, which strongly supported the legislation, has realized that the flavoring ban is not having its intended effect and now admits that the loopholes in the law are unacceptable. As the Times editorializes: "It makes no sense to ban flavors in cigarettes and then allow the industry to addict young people to flavored cigars."

The Times complains that: "Disturbingly, there are signs that some manufacturers, distributors and retailers may try to circumvent the ban by shifting young smokers to other flavored tobacco products, such as small cigars that may not quite fit legal definitions of a cigarette but can be made every bit as attractive to young smokers with a dash of chocolate, vanilla or fruit flavoring."

However, these manufacturers are not circumventing the law. They are actually following the clear dictates of the law, and the clear intention of the Philip Morris/Campaign for Tobacco-Free Kids Alliance which crafted the law, which was to ban flavorings in products without having any impact on actual tobacco sales: in other words, to ban flavored products that are actually not used very much, as opposed to flavored products which are a critical part of the market, especially for young people.

On this point, the FDA is now facing its second legal challenge to the Family Smoking Prevention and Tobacco Control Act: Kretek yesterday filed suit against the FDA to prevent the Agency from enforcing a ban on flavored cigars. Kretek is the leading importer of clove-flavored cigars.

The FDA, boxed into a corner because of the clear language and intent of the Philip Morris Monopoly Act, which exempts cigars from the flavoring ban, hedged and hawed to try to scare manufacturers of cigars and little cigars that their products are subject to the flavoring ban. Kretek will have no part of this attempt to re-write the clear meaning of the statute, and it is taking the FDA to court to make sure that the FDA does not misinterpret the clearly expressed desire of Congress, Philip Morris, and the public health groups to exempt cigars from the flavoring ban.

So because of the severe loopholes in the law, the FDA is already facing two lawsuits and the game has hardly just begun.

The first lawsuit against the FDA, which argues that the law violates the companies' First Amendment rights by restricting its truthful communication with consumers in an overly broad manner, was bolstered yesterday when it became apparent that R.J. Reynolds had broken the law by merely informing the public that it was complying with the cigarette flavoring ban, something which the law does not allow cigarette companies to do if it might lead consumers to believe that the products are now less harmful.

Since the Campaign for Tobacco-Free Kids and a host of other groups and policy makers, including the FDA and Health and Human Services Department themselves are informing the public that flavored cigarette products represent a special hazard, it could easily be construed that the law would not allow Reynolds to tell consumers that it is in compliance with the cigarette flavoring ban.

Reynolds wrote that all of its products "are in compliance" with the cigarette flavoring ban. But according to the law, cigarette companies may not make "any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that the product is safe or less harmful by virtue of its compliance with regulatory requirements set by the Food and Drug Administration."

That this simple, truthful, and appropriate statement by Reynolds might well be viewed in violation of the law is strong evidence that the law's infringement upon the free speech rights of cigarette companies is overly sweeping, and therefore unconstitutional.

The Rest of the Story

It is only a few months into its implementation, but the Family Smoking Prevention and Tobacco Control Act of 2009 is turning out to be a royal disaster. The law has accomplished absolutely nothing. Its loopholes -- compromises inserted by the public health groups to appease Philip Morris and protect its profits -- are so large that they ensure that the law will accomplish nothing.

Even supporters of the bill are beginning to realize that the hype over the bill's benefits was largely propaganda and they are urging the FDA to misinterpret the statute because it is clear that the statute as written is ineffective.

Meanwhile, the FDA is already mired in lawsuits that will tie up needed resources and will end up undoing even more of the legislation.

The Family Smoking Prevention and Tobacco Control Act of 2009 is full of sound and fury, but it signifies nothing. And while the intentions of the anti-smoking groups which crafted and supported the legislation may have been good, there was a fair amount of idiocy in thinking that any legislation crafted by and strongly supported by Philip Morris would do anything significant to protect the public's health.

Wednesday, September 23, 2009

The Truth: Not a Single Philip Morris or R.J. Reynolds Product Will Be Taken Off the Market Under Flavored Cigarettes Ban

According to statements from a number of anti-smoking groups and advocates in response to yesterday's implementation of the ban on flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act, the ban will break the cycle of addiction for millions of young people who start smoking each year by getting rid of products that are very popular among these kids due to their sweet candy and fruit flavors.

The Department of Health and Human Services was quoted as saying: "Flavored cigarettes attract and allure kids into lifetime addiction. The FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The Campaign for Tobacco-Free Kids stated: "As of today, tobacco companies will no longer be able to produce candy and fruit flavored cigarettes! While several provisions of law authorizing the Food and Drug Administration (FDA) to regulate tobacco products have already taken effect, this is one of the most significant. Thanks to the efforts of thousands of advocates like you, the president signed it into law and kids are now protected from the lure of products like Camel's Twista Lime, Kauai Kolada, Margarita Mixer, Warm Winter Toffee, and Winter Mocha Mint to name just a few. This is a great day for America's kids... ."

A sample letter to the editor which the Campaign for Tobacco-Free Kids is urging its constituents to send to local papers states: "Tobacco companies know that 90% of smokers started at or before the age of 18 and used candy flavorings for years to recruit new generations of customers. ... No longer will tobacco companies be able to produce cigarettes with brands such as Twista Lime, Kauai Kolada, Warm Winter Toffee and Winter Mocha Mint – which sound like candy. ... As an advocate who worked to pass this legislation into law, I’m thrilled that one of the first provisions to take effect will help keep another generation from falling prey to Big Tobacco’s deadly products."

The FDA was quoted as stating: "These flavored cigarettes are a gateway for many children and young adults to become regular smokers."

Senator Tom Harkin, a supporter of the Act, stated: "Banning the marketing and use of strawberry, chocolate and other flavored cigarettes will help slow the rate of addiction among young smokers, preventing disease and saving millions in health care costs down the line."

The Rest of the Story

The Campaign for Tobacco-Free Kids is telling the public that thanks to this new law, Camel's Twista Lime, Kauai Kolada, Margarita Mixer, Warm Winter Toffee, and Winter Mocha Mint will no longer be on the market and therefore, kids will now be protected from cigarette addiction.

However, the truth is that Camel's Twista Lime, Kauai Kolada, Margarita Mixer, Warm Winter Toffee, and Winter Mocha Mint were not on the market. R.J. Reynolds already withdrew them from the market several years ago after complaints from anti-smoking groups.

The rest of the story is that the new law will not result in the removal from the market of any cigarettes produced by Philip Morris or R.J. Reynolds - not a single one! Both Philip Morris and R.J. Reynolds have confirmed that they do not produce any flavored cigarettes that are covered by the ban, and thus, none of their products are affected by the new law.

The only products affected are a few flavored cigarette brands produced by minor cigarette companies that few youths were smoking to begin with. We have ample evidence of the brands that are responsible for youth addiction to cigarettes. Based on survey after survey, we know that these brands are Marlboro, Camel, and Newport. A full 87% of high school students who smoke are using one of these three brands.

None of these brands that are responsible for 87% of the cigarette market share among high school students contain candy or fruit flavors that are covered by the Family Smoking Prevention and Tobacco Control Act.

There is, however, one flavoring that actually is used in many of the brands that kids are smoking. It is a very common flavoring used in cigarettes popular among kids. Let me think for a minute. The name escapes me.....I am starting to recall it.... oh, yes, it's menthol.

The one flavoring that is actually playing a role in helping to initiate the cycle of addiction among youths is exempt from the legislation's flavored cigarette ban.

In other words, all of these quotes from anti-smoking groups, advocates, and policy makers are completely full of crap.

It is simply not true that the "partial" ban on flavored cigarettes is going to "break the cycle of addiction for the more than 3,600 young people who start smoking daily."

It is not true that Camel's Twista Lime, Kauai Kolada, Margarita Mixer, Warm Winter Toffee, and Winter Mocha Mint were taken off the market due to the new law. These products were already off the market.

It is not true that cigarette companies used candy flavorings for years to recruit generations of new customers. Unless you consider menthol to be a candy flavoring. What cigarette companies have been using to recruit new smokers is Camel, Newport, and Marlboro and in particular - menthol varieties of these brands.

It is also not true that "these flavored cigarettes [the banned ones] are a gateway for many children and young adults to become regular smokers." What is a gateway for many young people are menthol cigarettes.

It is also false that the flavoring ban will "help keep another generation from falling prey to Big Tobacco’s deadly products." The ban does nothing to help the next generation from falling prey to Big Tobacco products because it wasn't these flavored products to which they were falling prey!

Similarly, it is unscrupulously deceptive to claim that "banning the marketing and use of strawberry, chocolate and other flavored cigarettes will help slow the rate of addiction among young smokers, preventing disease and saving millions in health care costs down the line." It will do nothing of the sort because young smokers are not smoking strawberry, chocolate and other flavored cigarettes. They are, however, smoking menthol cigarettes in large numbers.

The rest of the story is that these anti-smoking groups are unscrupulously deceiving the public about the effects of the cigarette flavoring ban, making dishonest statements about the law's effects, and failing to tell the public that the one flavoring which would actually make a difference in youth smoking, if banned, was exempt in the law specifically to protect the interests of Philip Morris.

As the Alligatoreditorialized so insightfully, yet simply: "If the Food and Drug Administration wanted to prevent people from picking up smoking, menthol cigarettes would be included in the ban on flavored tobacco. On Tuesday, the sale of cigarettes flavored with anything other than menthol became illegal. According to The New York Times, mentholated cigarettes are exempt partly because they are viewed as politically off-limits. Without lobbyists from companies such as Philip Morris USA, the legislation to allow FDA regulatory power over the tobacco industry might not have ever passed. ... If the FDA was serious about preventing people from smoking, it would not make itself beholden to tobacco lobbyists worried about revenue losses and count menthol cigarettes as flavored."

And as I was quoted in yesterday's NPRstory about flavored cigarettes: "It doesn't make a lot of sense to me to say look, we're going to ban cigarette flavorings because they're so important, but we're going to exempt the one that's actually used the most. You know, you need to be consistent. If it's so important that we ban cigarette flavorings, then ban them."

According to the NPR story, Matt Myers of the Campaign for Tobacco-Free Kids responded by conceding "that regulating such a popular ingredient is a complicated task, far more so than banning exotic flavors like pineapple or grape."

In other words, it's easy to ban exotic flavors like pineapple and grape because no one is smoking them, so there's no opposition to banning them. But millions of people actually use menthol so it's complicated to ban it.

Fine, then don't ban it. But don't get in front of the American public and tell them that by banning the seldom-used grape and pineapple cigarettes, you have helped "keep another generation from falling prey to Big Tobacco’s deadly products."

Tuesday, September 22, 2009

A point-counterpoint set of columns regarding the proposed New York City ban on smoking in all parks appeared yesterday in USA Today. The paper's editorial argues that such bans go too far and cross the line by going beyond the scientific evidence of the significant harms of secondhand smoke. The opposing view, written by Americans for Nonsmokers' Rights (ANR), argues that the proposed smoking ban is needed to protect the health of nonsmokers.

The editorial supports smoking bans in workplaces and other confined places but suggests that to ban smoking in every park in New York City is far beyond what is necessary to protect nonsmokers from the hazards of secondhand smoke exposure.

It argues that: "To be harmed by secondhand smoke outdoors, you have to stand right next to the smoker and in the path of his smoke. Prolonged exposure in a park is improbable. New York's mayor, reformed smoker Michael Bloomberg, who has been laudably aggressive with anti-smoking campaigns, was right to respond hesitantly when his city health commissioner proposed this one. ... the gradual banning of smoking in confined spaces — airplanes, workplaces and the like — made sense. ... Government-imposed outdoor bans, though, are another matter. Rather than protecting innocent victims from harm, they amount to an intolerant majority infringing the personal freedom of an unpopular minority that is harming only itself. Just as people should be allowed to smoke in their own homes (unless they live in condos or apartments that have declared themselves smoke-free), they should also be allowed to smoke outdoors, where smoke is quickly dissipated and enforcement is problematic."

In its opposing view, ANR argues that outdoor exposure to secondhand smoke is a substantial public health threat and that to protect nonsmokers from even brief exposure to secondhand smoke, a ban on all outdoor smoking in public places, such as parks, is appropriate.

ANR argues that: "Smoke-free outdoor spaces are quickly becoming the national norm, and we have the science and public support to continue moving in this direction. Fueling interest in outdoor laws is the growing body of science on the negative health effects of secondhand smoke exposure outdoors and the environmental effects of cigarettes and toxic cigarette butts. In 2006, the California Air Resources Board classified secondhand smoke as a Toxic Air Contaminant and called it "an air pollutant which may cause or contribute to an increase in deaths or in serious illness." Additional research demonstrates that individuals with compromised cardiovascular systems might be at risk from brief exposures to secondhand smoke, even outside. People spending time outdoors near smokers over multiple hours, such as waitresses or dinner guests, can receive exposure that exceeds the Environmental Protection Agency's limit on fine particulate matter pollution. ... We applaud New York City for working to eliminate toxic contaminants and trash from parks and beaches, and expect to see more cities follow suit."

The Rest of the Story

As a researcher who has studied exposure to, and health consequences of, secondhand smoke for the past 24 years, I simply do not believe that the scientific evidence justifies New York City's proposed ban on smoking in all public parks as necessary to protect nonsmokers from any substantial health hazards. I find ANR's scientific argument to be non-compelling and I'm afraid by advancing such an exaggerated and unsupported argument, they are risking losing credibility on the issue of workplace smoking bans, where I believe the evidence is sufficient to warrant protection of nonsmokers.

In the long run, the extension of the smoke-free agenda to the wide open outdoors is going to harm our efforts to protect people from secondhand smoke in the places where they really need protection - workplaces, bars, casinos, and restaurants. Remember that while about half of states provide such protections for workers, half do not. The priority in tobacco control should be on extending protections from the severe hazards of secondhand smoke in workplaces to all workers throughout the country, focusing on the half of the states which do not afford workers such protections. The priority should not be on extending protections from secondhand smoke to the most remote areas within Central Park. In fact, the emphasis on the latter completely undermines the goal of achieving the former.

ANR's argument falls flat because while there is evidence that outdoor levels of secondhand smoke can be substantial in confined spaces, such as outdoor workplaces or arenas, there is no evidence that tobacco smoke exposure poses a hazard to nonsmokers in the wide open outdoors, unless one is standing directly next to the smoker. The levels of tobacco smoke diminish exponentially as you move away from the smoker. So if you are in Central Park, there is plenty of space to go to avoid any substantial exposure to secondhand smoke, even if you are someone who is particularly susceptible to smoke.

You are simply not going to convince me that in order to protect people's health, smoking needs to be banned within all areas of Central Park, even in remote areas. There may be other reasons why the City wants to ban smoking in Central Park, but you can't convince me that such a ban is necessary in order to protect citizens from substantial tobacco smoke exposure and health effects.

If ANR and other anti-smoking groups were honest, and they just admitted the real reasons they are supporting such laws, I would have a lot more respect for them. Trying to hide their true justification for these laws under the guise that these draconian restrictions are necessary to protect the health of nonsmokers just doesn't fly.

Why not simply admit that they believe that no nonsmoker should ever have to breathe in even a whiff of secondhand smoke, regardless of whether it would have any substantial health effects or not? Why not admit that they believe that clearing the air of smoke will make society healthier by helping to reduce smoking rates, since these draconian bans will likely cause many smokers to quit? Why not admit that they believe these laws are justified because preventing children from seeing smokers in public will help lower smoking initiation rates?

Why hide behind the scientifically unsupportable contention that banning smoking in every remote area of Central Park is absolutely necessary in order to prevent severe health effects that would otherwise occur?

Frankly, this really undermines the tobacco control movement's arguments for smoking bans in confined places - such as workplaces - where tobacco smoke truly does represent a substantial health hazard and where it actually is causing devastating health effects for many workers.

By focusing on the most remote areas of Central Park, I believe ANR is actually taking the focus off of, and undermining efforts to protect workers in the 25 or more states which do not presently protect all workers from very high levels of exposure to secondhand smoke.

Worse, ANR is undermining the scientific credibility of the tobacco control movement by making an unsupportable scientific claim. Better to just admit the truth and not hide behind an invalid and absurd scientific justification.

USA Today has now made ANR - and the rest of the anti-smoking movement, by association - look like a bunch of fanatics who are basing their policies not on science, but on unbridled zeal. This means that our opponents were right all along and that we are not supporting smoking bans because we have solid scientific evidence that these policies are necessary to protect the lives of nonsmokers. We're playing right into the opposition's hands. The question is: why?

Monday, September 21, 2009

Friday, I reported that the American Legacy Foundation has issued a policy statement calling for the FDA to pull electronic cigarettes from the market. I criticized this policy because it is essentially saying that Legacy would rather that ex-smokers who have successfully quit smoking using e-cigarettes return to conventional cigarette smoking, rather than remain off tobacco cigarettes. I argued that this undermines Legacy's own goal of promoting smoking cessation. Why condemn hundreds of thousands of ex-smokers to have to return to cigarette smoking and suffer the serious known health consequences? So many of these ex-smokers have already experienced a dramatic improvement in their health. It seems criminal to sentence these vapers to a return to the morbidity they were experiencing on regular cigarettes.

Up until this post, I had determined that every national anti-smoking group supporting a ban on electronic cigarettes had a substantial financial interest in Big Pharma, and specifically, in companies that manufacture traditional nicotine replacement medications and other cessation pharmaceuticals, and which are therefore threatened financially by the marketing of electronic cigarettes as an alternative to cigarette smoking, and as an alternative way to quit smoking (as opposed to using NRT products or other smoking cessation pharmaceutical aids).

The Rest of the Story

Today (thanks to comments by my readers to the previous post), I report that the pattern of every national anti-smoking group which has called for a ban on e-cigarettes being funded by Big Pharma is still intact. Because the rest of the story is that, as it turns out, the American Legacy Foundation is indeed funded by Big Pharma.

According to Legacy's web site, the Foundation receives support from Pfizer. The manufacturer of the smoking cessation drugs Chantix and Nicotrol NS is listed as a Legacy contributor. In addition, Pfizer has provided sponsorship support to help Legacy conduct a survey of physician support for smoking cessation. Not surprisingly, that study concluded that physicians must be urged to recommend more smoking cessation drugs for their patients. Also not surprisingly, the stop smoking program that Legacy runs insists upon pharmaceutical use by every individual trying to quit - no place for cold turkey quitting according to the Pfizer-sponsored American Legacy Foundation.

Particularly troubling is the fact that the American Legacy Foundation fails to disclose its financial conflict of interest with Big Pharma in its policy statement on electronic cigarettes (or in its quit guide on the Become an Ex web site). If you are going to issue a policy on electronic cigarettes, lobbying the FDA to ban these devices, I think you have an obligation to disclose any financial conflicts of interest that might be perceived as having a potential influence on your policy position. Certainly, financial support from a company that stands to lose millions from the sale of e-cigarettes constitutes a relevant conflict of interest that should be disclosed.

So the record remains intact. Every national anti-smoking group which has called for a ban on electronic cigarettes has a financial conflict of interest with Big Pharma. Moreover, these conflicts of interest have not been disclosed in the policy statements issued by these organizations. Here, the American Legacy Foundation has issued a policy statement on e-cigarettes without disclosing that it receives funding from Pfizer, which stands to lose financially from the continued sale of these products, which are now directly competing with Pfizer products for the smoking cessation market.

This is a conflict of interest that should, and must, be disclosed. To hide such a conflict in statements regarding national policy is, in my view, unethical.

Friday, September 18, 2009

The American Legacy Foundation has joined the list of anti-smoking organizations which are pushing for the prohibition of the sale and marketing of electronic cigarettes. The Foundation has released a policy statement, which calls for the FDA to pull e-cigarettes off the market because Legacy claims that these products are not known to be "safe and effective."

According to the policy statement: "The FDA should take electronic cigarettes off the market until it is satisfied that they are safe and effective." Given that the average time it takes for drug companies to conduct clinical trials and demonstrate the safety and efficacy of their products is about 8 years, this would mean the removal of electronic cigarettes from the market for about 8 years.

The American Legacy Foundation expressed concern that "the FDA detected carcinogens, including nitrosamines. In other words, these analyses showed that the tested products contained detectable levels of known carcinogens and toxic chemicals."

The Rest of the Story

The rest of the story is that what the American Legacy Foundation is calling for is the return of hundreds of thousands of ex-smokers to cigarette smoking, and the return of a huge amount of lost profits to Big Tobacco.

Given that a major goal of the American Legacy Foundation is to encourage smokers to quit and keep them off cigarettes, it is quite ironic that Legacy would support a policy that would do exactly the opposite: force hundreds of thousands of vapers to return to analog cigarettes.

Legacy has long had a problem with hypocrisy: as I reported on this blog, it partnered with organizations that were the chief causes of youth exposure to smoking in movies at the same time as it decried the problem of smoking in movies. It gave an award to the very company that was responsible for delivering cigarette ads to millions of children at the same time as it bemoaned the problem of youth exposure to cigarette ads in magazines.

Now, the hypocrisy is more serious, because if the policy is adopted, it will actually result in the loss of lives. On the one hand, Legacy wants smokers to quit and stay off of cigarettes. On the other hand, Legacy is telling hundreds of thousands of ex-smokers who have done exactly as they were told and gotten off cigarettes that they are going to have to return to cigarette smoking because there are traces of carcinogens in e-cigarette cartridges.

Am I getting this right? Legacy wants ex-smokers to return to cigarette smoking because the organization is worried about the fact that there are traces of carcinogens in electronic cigarettes. But the truth is that the regular cigarettes don't merely have traces of carcinogens, they are loaded with them, to the order of 1400 times higher a concentration of the very same carcinogens that were detected in e-cigarettes.

Given the known hazards of cigarette smoking and the disease and death that it causes, why is Legacy worrying about the merely hypothetical risk associated with a product that delivers nicotine but without the 10,000 plus other chemicals? Electronic cigarettes have been on the market for more than three years, and there are no known adverse effects. You would think that if there was some deep, dark secret about the product that was causing serious risk to users, we would have heard about it by now. We've certainly heard about the serious risk caused by Chantix, which is associated with death as an adverse side effect, yet the same organizations calling for a ban on e-cigarettes have no problem with Chantix remaining on the market.

Legacy has expressed concern that electronic cigarette cartridges were found to contain nitrosamines. But the levels of nitrosamines in e-cigarettes are miniscule, much lower than what is present in tobacco cigarettes, and on the order of what is present in approved products such as nicotine gum and nicotine patches. Studies have documented that there are detectable levels of nitrosamines in nicotine gum and patches, but I don't see Legacy calling for the removal of those products from the market.

If Legacy is truly concerned about exposure to nitrosamines, then the last thing in the world it should do is call for a ban on electronic cigarettes. The level of nitrosamines in Marlboros is 1400 times higher than in electronic cigarettes.

So what Legacy is saying to vapers makes no sense: "We are concerned about your exposure to nitrosamines. So we'd like you to return to a product that has 1400 times higher the level of nitrosamines for the next 8 years, while we do studies to determine whether the product that has only traces of nitrosamines is better for you than smoking your Marlboros. So keep puffing away on your Marlboros for the next 8 years, and if you're still alive after that, we'll let you know that it's OK to go back to the electronic cigarette."

There seems to be a lack of understanding of basic principles of toxicology, epidemiology, and biological science. There is simply no way that a product which contains traces of carcinogens - and no other known toxic chemicals - could be more dangerous than a product which contains high levels of more than 40 known carcinogens and delivers more than 10,000 chemicals in addition to the nicotine.

What about the diethylene glycol? The same diethylene glycol is present in regular cigarettes, so what sense does it make to tell vapers: "We're worried about diethylene glycol exposure, so return to your regular cigarettes, which contain diethylene glycol, even though your brand of e-cigarettes may not actually expose you to diethylene glycol."

If the real concern is over diethylene glycol, then why not simply ask the FDA to take off the market those brands of e-cigarettes that contain diethylene glycol? That would pretty much solve that problem, no? Why force all vapers to return to cigarette smoking when there is only one brand of e-cigarettes that has been found to have this problem? Why not simply test all the brands and then force the companies selling brands with diethylene glycol to stop selling their products until they get rid of it?

And by the way, it is troubling that Legacy is making a big fuss over diethylene glycol detected in one cartridge of electronic cigarettes (without any evidence that the diethylene glycol makes its way into the vapor that is actually inhaled), yet Legacy has issued no concern about, and no warning to smokers about the diethylene glycol that we know smokers are inhaling and which is actually known to be present in the inhaled smoke.

If Legacy wants to do something that may actually improve the public's health, rather than increase disease and death by forcing ex-smokers to return to cigarette smoking, how about putting out a public relations campaign telling smokers that they are breathing in an ingredient found in anti-freeze?

Why is the diethylene glycol only a concern to Legacy when present in the non-tobacco cigarette, but not when present in the tobacco cigarette? Shouldn't we be sounding the alarm to smokers that they are inhaling a component of anti-freeze? Why only spread this alarm among people who have already succeeded in quitting smoking? And if we're trying to protect people from inhaling diethylene glycol, what point is there in telling vapers to return to cigarette smoking, where we know that they will be exposed to diethylene glycol?

And lest anyone argue that removing e-cigarettes from the market will result in vapers deciding to give up nicotine products completely, the vapers themselves have made it very clear that this is not the case. Anyone who believes that pulling e-cigarettes from the market will result in hundreds of thousands of vapers successfully becoming completely abstinent from nicotine may be interseted in purchasing a bridge down in lower Manhattan.

What is so disturbing to me about this policy statement from Legacy is not that it takes the position of calling on the removal of e-cigarettes from the market, but that it is based on such a complete misunderstanding of science, such an ignorance about the reality of what is going on in the world out there, and such a misrepresentation of the demonstrable facts about what FDA's lab testing - and other lab testing of e-cigarettes - has actually revealed.

By calling on the removal of e-cigarettes from the market, the American Legacy Foundation is greatly undermining its own goal of promoting smoking cessation and it is providing tremendous assistance to Big Tobacco in getting hundreds of thousands of former customers to return to their smoking addiction, and to return to padding Big Tobacco's pockets. The tobacco companies could not possibly be happier with their supporters at the American Legacy Foundation.

Thursday, September 17, 2009

After thinking some more about the Iceland smoking ban/heart attack study, I feel obligated to comment further on the poor quality of the science of this study, not only because it invalidates the conclusion of this particular study, but because it demonstrates a striking bias that is present in all of the studies of this type and therefore has implications for evaluating the entire field of research in this area.

It turns out that the Iceland study was the topic of a poster presentation at the NBCC conference in June (see abstract P053). Here are the details of the study:

"Introduction: Possible effects of a smoking ban in public places on the incidence of acute coronary syndrome (ACS) are unknown. We hypothesised that such a ban would decrease the incidence of ACS among non-smokers in Iceland.Material and methods: Nationwide data was gathered prospectively on all patients that underwent coronary angiography for ACS during the 5 months prior to and following the smoking ban. Current smokers were excluded. ACS was defined as: clinical symptoms of unstable coronary artery disease (chest pain at rest) as well as at least one of the following 1) elevated cardiac enzymes, 2) ischemic changes on the EKG at rest, or 3) an abnormal exercise stress test during the same unstable episode.Results: Totally 378 patients were included in the study. Males were 281 and females 97 (p<0.01). Women were 24% vs. 28%, hypertensive’s 54% vs. 65%, former smokers 65% vs. 67%, 57% vs. 56% were on statin therapy, and 16% vs. 16% had diabetes before and after the ban, respectively (p=ns for all). Among men a 21% reduction of the ACS incidence was seen during the 5 months following (n=124), compared to the 5 months prior to (n=157) the ban (p<0.05). In the total population a trend was seen towards a 17% reduction in ACS (p=0.08). No effect was seen among women (0.5%, p=ns).Conclusions: A significant 21% reduction in the incidence of ACS was seen among non-smoking men, but not among women, after a smoking ban in public places became effective in Iceland."

The Rest of the Story

Like the abstract presented at the European Society of Cardiology conference earlier this month, this abstract does not mention the date (month and year) in which the smoking ban was implemented in Iceland. Given that this study examined only five months prior to and five months after the smoking ban, it seems quite important for the abstract to reveal the specific months that were included in the study.

Why? Because there is a well-recognized seasonal variation in acute coronary syndrome, with peak incidence during the winter months, high incidence during the spring and the lowest incidence during the summer. This is recognized in the literature as a universal phenomenon (see Cheng TO. Seasonal variation in acute myocardial infarction. International Journal of Cardiology 2009; 135:277-279).

Cheng explains the reasons for this observation: "Cold temperature in the winter can cause increased cardiac workload, higher coronary and vascular resistance, higher blood pressure and higher fibrinogen levels, all of which are conducive to acute myocardial infarction. That it is the colder environmental temperature in the winter in most parts of the world rather than the winter season per se that is the principal reason for increased hospital admissions for acute myocardial infarction is evidenced by the observation that the peak month of acute myocardial infarction admitted to hospitals in Melbourne, Australia was July, which is the coldest month of the year."

Given this seasonal variation in heart attacks, I was surprised to find out that the smoking ban in Iceland went into effect on June 1, 2007. This means that the pre-ban period included the months of January, February, March, April, and May. And the post-ban period included the months of June, July, August, September, and October.

The average temperatures (degrees Centigrade) during the pre-ban months in Reykjavik are: 1.9, 2.8, 3.2, 5.7, and 9.4. The average temperatures during the post-ban months are: 11.7, 13.3, 13.0, 10.1, and 6.8.

Thus, based on seasonal variation alone, one would expect to observe a much lower incidence of acute coronary syndrome in Iceland during the period of June through October compared with the period of January through May. One would expect acute coronary syndrome incidence to peak in the winter (the pre-ban period), remain high in the spring (also pre-ban period), and to wane in the summer (the post-ban period).

Thus, the study methodology is basically a set-up to detect a reduction in the incidence of acute coronary syndrome. The fact that the abstract reports finding an overall 17% reduction is not at all surprising given the months during which these data were collected. One would expect a 17% reduction based on the seasonal variation alone.

In fact, one of the most comprehensive studies of seasonal variation in acute myocardial infarctions found that there is a 40% reduction in the incidence of heart attacks in the summer compared to the winter and spring (see: Rumana et al. Seasonal pattern of incidence and case fatality of acute myocardial infarction in a Japanese population [from the Takashima AMI Registry, 1988 to 2003]. American Journal of Cardiology 2008; 102: 1307-1311).

Therefore, the study results, as taken from the information provided in the study abstract, do not support a conclusion that the smoking ban had any effect on reducing acute coronary syndrome incidence in Iceland.

But what strikes me, after thinking about this for a few days, is just how bad this science is. I just don't see how any objective scientific study of this issue would fail to account for the seasonal variation in acute coronary syndrome, especially when the post-ban months are precisely those in which one would expect the incidence to go down.

If the same study were conducted by the tobacco industry, we would be blasting the companies for intentionally rigging the study to find their pre-determined conclusion.

I tried to give the study a chance by searching to see whether perhaps it did adjust for seasonal variation but that the adjustment was not apparent. However, when you look at the actual numbers reported, you'll see that there was no adjustment.

The study reports a decline of acute coronary syndrome cases among men from 157 to 124. This is a 21% reduction, which is what the study reports. Thus, the study is simply reporting the percentage decline in the number of cases. There is no adjustment for seasonal variation in acute coronary syndrome incidence.

While I'm not arguing here that the study was intentionally rigged to try to make it look like the smoking ban had an effect, the fact that the study appears to have completely ignored the well-recognized seasonal variation - which in this case is a fatal flaw of the study, completely invalidating the study conclusion - suggests that a very strong bias is present. Unfortunately, I find this to be the case with nearly all of the studies that have been published on this topic of the immediate effects of smoking bans on heart attack incidence.

I understand that researchers in tobacco control very much want there to be an immediate effect of smoking bans on heart attacks. Of course we want to be able to say that our efforts have resulted in an immediate reduction in severe morbidity and mortality. But we cannot and should not abandon rigorous scientific standards to try to show that there is such an effect.

Wednesday, September 16, 2009

According to an article at NY1, New York City Health Commissioner Dr. Thomas Farley explained that the reason behind the city's proposal to ban smoking in all parks is not to protect people from secondhand smoke, but to prevent children from even having to see a smoker in public.

The Health Commissioner was quoted as stating: "We don't think children should have to watch someone smoking."

The New York Times also reported that the Health Commissioner described the smoking ban in public parks as being intended not to protect nonsmokers, but to get smokers to quit by making it harder for them to light up in public.

According to the article in the Times, "Dr. Farley said the ban—which officials said may require the approval of the City Council, but could possibly be done through administrative rule-making by the city's Department of Parks and Recreation—was part of a broader strategy to further curb smoking rates, which have fallen in recent years."

The Rest of the Story

Make no bones about it. Anti-smoking advocates are now promoting smoking bans for the purpose not of protecting nonsmokers from the hazards of secondhand smoke, but of protecting nonsmokers from even having to see smokers in public. And they readily admit it.

For many of my 24 years in tobacco control, the clearly stated goal of the smoke-free movement was to protect nonsmokers from secondhand smoke by promoting bans on smoking in the workplace and public places. The goal was never to prevent people from seeing smokers. We were talking about a serious health hazard - high levels of direct exposure to a hazardous mix of chemicals in tobacco smoke from other people.

Now, the movement has apparently deteriorated to the point where it is promoting smoking bans simply to prevent people from having to see others smoking.

From an anti-smoking perspective, this is troublesome because I think it will really hurt the cause. It is going to make it more difficult to promote legitimate smoking bans - those which protect workers from substantial exposure to secondhand smoke - in the states which currently do not have workplace or restaurant/bar smoking bans. If we are viewed (now rightly so) as anti-smoking zealots who merely don't want to have to see people smoking in public, then our arguments for intervening in the workplace to eliminate secondhand smoke are greatly undermined.

From a broader public health perspective, this is troublesome because it sets a tremendously bad precedent to ban unhealthy behaviors in public simply because we don't want children to see those behaviors. What's next? Are we going to prohibit people from eating french fries in public because it sets a bad example for kids? Are we going to prohibit the sale of those delicious New York City pretzels because children are seeing the consumption of an unhealthy amount of salt in one sitting? Are we going to prohibit obese people from entering public parks because it sets a bad example?

What the justification being provided for this law does is define smoking as an immoral, rather than simply unhealthy behavior. We generally do not ban unhealthy behaviors in public to protect people from seeing them. The justification for banning certain types of public behavior is either that the behavior harms others or puts them at risk or the behavior violates the public morals. It seems to me that smoking in a wide-open city park does neither. But by justifying banning smoking by arguing that children will see people smoking, city officials are essentially defining smoking as being a violation of the public morals.

I do find it dangerous to set such a precedent, because it is only a small step in logic to use the same reasoning to justify banning obese people from entering public parks. If the justification for not allowing smoking in public is that it sets a bad example for children, then the same reasoning would also support banning obese people from public parks, or also banning a host of other behaviors, from eating Nathan's fries to salted pretzels to high-calorie, colored sugar water (i.e., Coke and Pepsi) in public. I don't understand the singling out of smoking.

What saddens me the most is the loss of the science-base to the tobacco control movement. Not only is the rigor of our science going down the tubes, as I have demonstrated during the past 2 days with these very seriously flawed smoking ban/heart attack studies, but now the science-based justification for our promoted policies is also going down the tubes. Ultimately, I feel this is going to hurt even our legitimate pursuits, such as trying to protect workers from the very real hazards of high levels of secondhand smoke exposure.

Tuesday, September 15, 2009

Not a day went by after reporting the use of science by press release to disseminate results of a study of the effect of England's smoking ban on heart attacks before the same tactic of science by press release was used to disseminate the preliminary findings of another smoking ban/heart attack study.

Heartwire reported yesterday the results of a new study in Iceland, presented at the 2009 meeting of the European Society of Cardiology, which reportedly showed that the occurrence of acute coronary syndrome (heart attacks and unstable angina) declined in Iceland during the first five months following implementation of the country's ban on smoking in restaurants and bars, which went into effect in June 2007. According to the article, the incidence of acute coronary syndrome declined by 21% among men, but did not decline among women. The study authors conclude that the effect was due to the smoking ban, and that this finding is consistent with the other literature on this topic.

Because this is science by press release, the full study is not available, so there is limited opportunity to scrutinize the methods, results, and conclusions to assess the validity of the study. Neverthless, the findings will be widely disseminated by the media, spreading the conclusion that the smoking ban in Iceland resulted in an immediate 21% decline in the incidence of acute coronary syndrome.

The Rest of the Story

I find it very curious that the study abstract does not mention the date (month and year) in which the smoking ban was implemented in Iceland. Given that this study examined only five months prior to and five months after the smoking ban (which itself is quite odd - why not wait until you have a full year's data), it seems quite important for the abstract to reveal the specific months that were included in the study.

Why is this important? For a very simple reason: there is a well-recognized seasonal variation in acute coronary syndrome, with peak incidence during the winter months, high incidence during the spring and the lowest incidence during the summer. This is recognized in the literature as a universal phenomenon (see Cheng TO. Seasonal variation in acute myocardial infarction. International Journal of Cardiology 2009; 135:277-279).

Cheng explains the reasons for this observation: "Cold temperature in the winter can cause increased cardiac workload, higher coronary and vascular resistance, higher blood pressure and higher fibrinogen levels, all of which are conducive to acute myocardial infarction. That it is the colder environmental temperature in the winter in most parts of the world rather than the winter season per se that is the principal reason for increased hospital admissions for acute myocardial infarction is evidenced by the observation that the peak month of acute myocardial infarction admitted to hospitals in Melbourne, Australia was July, which is the coldest month of the year."

Given this seasonal variation in heart attacks, I was surprised to find out that the smoking ban in Iceland went into effect on June 1, 2007. This means that the pre-ban period included the months of January, February, March, April, and May. And the post-ban period included the months of June, July, August, September, and October.

The average temperatures (degrees Centigrade) during the pre-ban months in Reykjavik are: 1.9, 2.8, 3.2, 5.7, and 9.4. The average temperatures during the post-ban months are: 11.7, 13.3, 13.0, 10.1, and 6.8.

Thus, based on seasonal variation alone, one would expect to observe a much lower incidence of acute coronary syndrome in Iceland during the period of June through October compared with the period of January through May. One would expect acute coronary syndrome incidence to peak in the winter (the pre-ban period), remain high in the spring (also pre-ban period), and to wane in the summer (the post-ban period).

Thus, the study methodology is basically a set-up to detect a reduction in the incidence of acute coronary syndrome. The fact that the abstract reports finding an overall 20% reduction is not at all surprising given the months during which these data were collected. One would expect a 20% reduction based on the seasonal variation alone.

In fact, one of the most comprehensive studies of seasonal variation in acute myocardial infarctions found that there is a 40% reduction in the incidence of heart attacks in the summer compared to the winter and spring (see: Rumana et al. Seasonal pattern of incidence and case fatality of acute myocardial infarction in a Japanese population [from the Takashima AMI Registry, 1988 to 2003]. American Journal of Cardiology 2008; 102: 1307-1311).

Therefore, the study results, as taken from the information provided in the study abstract, do not support a conclusion that the smoking ban had any effect on reducing acute coronary syndrome incidence in Iceland.

By the way, this is precisely why peer review is essential and why science by press release is so problematic. The apparent failure to consider seasonal variation in heart attack incidence is likely something that would be picked up in a vigorous peer review. It would become apparent that the study results are invalid. But now, it is too late. Even if this is picked up in peer review, it is almost moot because the results and conclusion have already been widely disseminated.

Are the study authors going to pull an Emily Litella and put out a subsequent press release that says: "Never mind." I doubt it. And even if they did, it's too late anyway because the conclusion has already been so widely disseminated.

I should also point out that even ignoring the seasonality issue, the abstract itself does not report a significant effect of the smoking ban on heart attacks. In the overall study population, the level of significance associated with the observed decline in heart attacks was 0.08. In other words, it did not meet the 0.05 level of significance and the study cannot conclude that there was a significant effect of the smoking ban.

The study authors do two things to try to create the appearance of a significant effect.

First, they stratify the results by gender (there is no a priori reason to do this, since the study hypothesis was not that the smoking ban would only affect heart attacks among men). While they report a significant effect for men, there is no effect for women. Such a finding argues strongly against the hypothesis that the smoking ban was the cause for the decline in acute coronary syndrome, since if the effect were due to secondhand smoke exposure reduction, one would expect to observe the effect among both men and women.

Second, rather than honestly reporting the results of the study - that they found no significant effect of the smoking ban on heart attacks overall, they twist the words that are used to describe this finding, and instead, they state that: "In the total population a trend was seen towards a 20% reduction in ACS (p=0.08)."

No trend was seen toward a 20% reduction. What the study found was that there was no significant reduction in acute coronary syndrome. By twisting the way they report this finding, the authors appear to be trying to make it sound like there was a significant effect when there was not one. This type of language is not appropriate, in my opinion.

When you read a study that reports a result "trended toward significance," what the authors are really saying is: "We did not actually find a significant effect, but we wanted to, and we are afraid to actually state they we didn't find a significant effect, so instead we're going to hide our failure to find significance by saying that the results 'trended' toward significance.

Today, I don't what is worse: the fact that the results of the study were disseminated by press release rather than by peer review and publication, the fact that the study apparently failed to account for seasonal variation in the incidence of acute coronary syndrome, or the fact that the paper actually found no significant effect of the smoking ban on acute coronary syndrome but tried to disguise that finding - which, after all, is the critical finding of the entire study.

Monday, September 14, 2009

As reported widely by newspapers in the UK in the past few days, a new study has purportedly found that in the year following the smoking ban which was implemented in England in July 2007, heart attacks fell by 10%, an effect the researchers conclude is due to the smoking ban (Times Online story; Yahoo! story; Telegraph story; Mail Online story).

According to the Mail Online article: "The ban on smoking in public has led to a dramatic fall in heart attack rates, it was claimed today. Researchers say the number of heart attacks in England plummeted by 10 per cent in the year after the ban was imposed in July 2007. A similar drop was also recorded in Scotland where another study discovered a 14 per cent decrease in the year after the ban was introduced there. A third study is currently underway in Wales."

"The latest figures - compiled for the Department of Health - will inevitably increase the pressure on the government to widen the ban to other areas. Ministers have already commissioned a study into the possibility of banning smoking in all cars. And there are now calls from anti-smoking groups for parents to be banned from smoking in front of their children at home." ...

"Anna Gilmore, from Bath University, is leading the research into heart attack rates in England. She said: 'There is already overwhelming evidence that reducing people's exposure to cigarette smoke reduces hospital admissions due to heart attacks.' The final results for England, however, will not be published until next year."

The Rest of the Story

It turns out that there is no "study" to behold. The "study" appears to merely be a work in progress that has not yet been published or even submitted for publication, yet its results and conclusion were widely disseminated through the media. In other words, this is yet another example of what I call "science by press release."

It appears that the conclusions of the study have been released to the media, but that the actual research itself is not being made publicly available. The study itself is not available, from what I can tell, on the University of Bath web site or the web site of the UK Centre for Tobacco Control Studies.

Therefore, it is impossible to judge whether the conclusions of the study are valid or not. And if the conclusions turn out to be unwarranted, then it will be too late to reverse them. The media have already disseminated the conclusion widely. Any correction given down the road would have little effect.

In most cases, I believe the results of a scientific study should not be released to the media prior to publication. However, if the results of a study are going to be released to the media at this conference, then I believe it is imperative that the study itself be made available for public scrutiny. You can't just release the conclusions, but not the study itself.

Moreover, if the manuscript is going to be submitted for publication, then it may be inappropriate to release the findings to the media prior to publication. Many journals have explicit policies that preclude the authors of submitted manuscripts from releasing the results to the media until publication.

It is problematic that the study authors have apparently released their results and conclusions to the media but that they have not released the full results and methods of the study because without the full methods and results, it is not possible for others in the field to adequately review the work and assess its validity. I personally feel that researchers should not publicize study findings through the media prior to publication unless they are willing to make the full findings and methods available. Releasing results via press release to the media should not be done until publication, or if it needs to be done before publication, then it should only be done with concomitant release of the entire study.

When the study is finally released, it will be very interesting to see how the researchers came up with the finding of a 10% decline in heart attacks in England during the first year following the ban. According to Christopher Snowdon at Velvet Glove Iron Fist, National Health Service statistics show that there was only a 2% decline in heart attack admissions in England from 2006-07 to 2007-08, compared to a 2.8% decline in the preceding year and a 3.8% decline in the year preceding that. Thus, these data show no evidence that the smoking ban resulted in any significant, immediate decline in heart attacks.

Furthermore, if you graph the trends in heart attacks in England using the NHS data, you will see no apparent change in the small but steady decline in heart attack admissions that has been observed since 2002.

In 2007-2008, there were 54,759 emergency room heart attack admissions in England. During the preceding year (2006-2007), there were 56,889 admissions. This is a decline of 3.7%.

What was the decline in heart attack admissions in England during the prior year? Also 3.7%. And the year before that? 3.8%.

As one can see visually, there is absolutely no change in the trend of declining heart attack admissions in England during the first nine months during which the ban was in effect. There appears to be a relatively steady decline in heart attack admissions from 2002-2008, with no change associated with the smoking ban.

Thus, this analysis confirms that no matter how you look at it, there was no change in the rate of declines in heart attack admissions in England associated with the first nine months of the smoking ban.

Given these findings from the national data, it will be very interesting to see how the researchers have come up with the finding of a 10% decline in heart attacks during roughly the same time period.

Unfortunately, because this is science by press release, we have no idea of how the researchers came up with their 10% figure, what methods they used, what data this figure is based on, and whether there is any validity to their conclusion that the observed decline in heart attacks is attributable to the smoking ban, rather than to the established secular trend of declining heart attacks over the past seven years in England.

What strikes me as particularly odd is that so many of these examples of science by press release are coming in a single area of research: the effects of smoking bans on heart attacks. For some reason, anti-smoking researchers in this area of inquiry have largely abandoned the usual scientific approach and instead have adopted the science by press release tactic. Why is this?

Perhaps the clue comes in the second part of the Mail Online article I cited above, where it reports that these new data are going to be used to pressure government officials to ban smoking in private cars and homes where children are present. It appears that many anti-smoking groups and advocates believe that these conclusions are needed to put pressure on government officials to ban smoking in cars and homes, apparently the next item on the anti-smoking agenda. But rather than wait until rigorous, peer-reviewed studies have been conducted to determine the impact of smoking bans on heart attacks, advocates are using science by press release to disseminate premature conclusions that will most likely not be borne out by subsequent scientific scrutiny.

Of course, it will be too late once the truth comes out, because these policies will already have been enacted on the basis of the premature conclusions that were disseminated by press releases, rather than by scientific journals.

I guess that's exactly the point, but it's really sad for me to see. The scientific integrity of the tobacco control movement is imploding before my very eyes.

Friday, September 11, 2009

A press release issued by Northwestern University this past Wednesday announced the recommendations of a new study, which concludes that all smoking patients being treated for mental illness should be treated with pharmaceuticals in an effort to help them quit smoking. The lead author of the study is Dr. Brian Hitsman with Northwestern University. The senior author is Dr. Tony George of the University of Toronto.

According to the press release: "when mental health providers insert smoking cessation treatment into the mental health treatment plan, they can help their patients quit or cut down. 'They find if you take advantage of the relationship with the counselor and insert smoking cessation counseling into treatment that you enhance quit rates,' Hitsman said. His tobacco cessation plan combines cognitive behavioral therapy, pharmacotherapy and motivational counseling to help the patient quit. Hitsman also has identified several treatment medications that may further facilitate quitting for this population. ... Tobacco dependence also needs to be treated as a chronic disease, Hitsman believes. 'We know that treatment provided for a longer duration substantially increases the abstinence rates of people without mental disorders,' he noted. 'Smokers with mental illness may be especially likely to benefit from extended or maintenance tobacco treatment.'"

The paper itself sets forward an algorithm in which nicotine replacement therapy, Zyban, or Chantix is prescribed for every patient in an effort to help them quit smoking, and even after successful cessation, pharmaceuticals are prescribed for up to an additional 12 months to prevent relapse.

The Rest of the Story

Nowhere in the press release is it revealed that the lead author and senior author of the paper have financial conflicts of interests with Big Pharma.

According to the published study:

Dr Hitsman has consulted for Pinney Associates, subcontracted by GlaxoSmithKline (2006); and

Dr George has received grant support from Pfizer, Sepracor, Targacept, and Sanofi-aventis, and is a consultant to Pfizer, Prempharm, Glaxo-SmithKline, Eli Lilly, Janssen-Ortho, and Evotec.

Pfizer is the manufacturer of Nicotrol and Chantix. GlaxoSmithKline is the manufacturer of Zyban and NiQuitin.

The rest of the story, therefore, is that two of the authors of this study have financial conflicts of interest with Big Pharma, and specifically, with companies that manufacture the very smoking cessation drugs that they are recommending be used with every patient.

There is nothing wrong with the investigators making this recommendation. However, it is incumbent upon them, I believe, to disclose their conflicts of interest in every communication that disseminates their findings to the media or the public. While the conflict was disclosed in the published article itself, it was apparently not disclosed in the press release. This means that the results of the study, with its recommendation that pharmaceuticals be used with every smoking patient, are being disseminated throughout the world without any disclosure of the relevant (and imporant) conflict of interest.

I don't understand why researchers believe that if there is a conflict of interest important enough to be disclosed in a published manuscript, it is not important enough to be disclosed in a press release about that manuscript, which is likely to be disseminated worldwide, and to be seen by far more people than the article itself.

There is little question that more people will see the press release than will see the actual study. So if anything, it seems even more important to disclose the conflict of interest in the press release.

I believe that medical journals should consider expanding their conflict of interest disclosure policies to require that authors of papers disclose their conflicts in any press releases issued regarding the article.

Similar, universities should ensure that disclosure of conflicts of interest is made not only in published articles, but in press releases issued about those articles. Since it is the university itself which is issuing these press releases, it seems it is even more incumbent upon the institution to disclose the relevant conflicts of interest.

Thursday, September 10, 2009

Anti-smoking groups are now arguing that e-cigarette use sidetracks smokers who would otherwise quit smoking completely, thus leading to more smokers.

According to a Public News Servicearticle: "Health advocates think Kentucky should follow Oregon's lead in stamping out electronic cigarettes. Oregon was the first to ban the sale of the new products, also called "e-cigarettes," but they are still available elsewhere, including in Kentucky. ... Ellen Hahn, director of the Kentucky Center for Smoke-Free Policy, says e-cigarettes could actually end up creating new customers for tobacco in a state where adult and youth smoking rates are at epidemic levels. 'They're mistakenly marketing them as a safe alternative to cigarettes, where there are no age restrictions, and so the way they are marketed really does appeal to children.' ... She says it would be a bad idea for Kentucky smokers, who are trying to quit their habit, to get hooked on alternatives to smoking. 'The thing that scares me most in Kentucky particularly is because we have so many tobacco-dependent people. These products, e-cigarettes and other products, really will derail smokers who actually want to quit and instead they may switch to these products.'"

The Rest of the Story

Once again, the logic of this argument by anti-smoking groups eludes me: If a person switches from cigarettes to electronic cigarettes, he or she is no longer a tobacco-dependent person.He is no longer a smoker. So e-cigarette use doesn't increase smoking, it decreases it. It doesn't create new customers for tobacco, it reduces tobacco use.

This is the classic abstinence only argument and just as it fails with regards to arguing against sex education in schools, methadone maintenance programs, and needle exchange programs, it also fails with respect to electronic cigarettes.

The argument being used by the Kentucky Center for Smoke-Free Policy is tantamount to arguing that we should not promote methadone maintenance programs because they are going to increase heroin use.

Even if we accept the argument that people who would otherwise quit smoking completely are going to be sidetracked into vaping instead, it is demonstrably false that this increases the number of smokers or brings new users to tobacco products. By definition, it lowers the number of tobacco users. It takes people away from smoking. While it would be legitimate to argue that e-cigarettes create more people who continue to be addicted to nicotine rather than being nicotine-free, it is false that this method of smoking cessation creates new smokers.

What would create new smokers in Kentucky is precisely the policy for which the Center for Smoke-Free Policy is arguing: banning e-cigarettes in the state. Doing so would instantly create thousands of new smokers. Without a doubt, thousands of vapers in Kentucky -- ex-smokers -- would return to cigarette smoking and the use of tobacco products if e-cigarettes were banned in the state. If you want to do anything to create new tobacco users in Kentucky, banning e-cigarettes would actually be the most effective way to accomplish that objective.

What strikes me is that these health officials in Kentucky are arguing for a policy that will have the effect of accomplishing exactly the opposite of what they say they are trying to achieve. If the goal is to reduce the number of tobacco-dependent people in Kentucky, then the last thing in the world you want to do is ban e-cigarettes, and force thousands of Kentuckians to return to cigarette smoking.

We can debate about whether or not people who quit smoking by switching to e-cigarettes are people who would have quit nicotine use completely, but it is demonstrably false to assert that by switching to e-cigarettes, they are continuing to be smokers or tobacco users. They are not. Thy are ex-smokers. They are ex-tobacco users.

It boggles my mind that anti-smoking groups can't seem to recognize this fact. They seem obsessed with the idea that if someone is vaping, they are still smoking cigarettes and still using tobacco. This is false. They are actually ex-smokers who are no longer using a tobacco product. Of course, there is an issue about their continued addiction to nicotine (just as methadone users continue to be addicted to opiates), but the amount of harm reduction achieved by the switch from smoking to vaping is immense.

It seems that the fact that vapers are going through a behavioral act that is akin to smoking is what is important to anti-smoking groups, rather than the actual health effects - or relative health effects - of the behavior. I thought we were trying to save lives. But it appears that we are instead trying to prevent people from going through the motions of bringing a device to their mouth and inhaling.

Keep in mind, also, that nicotine-free electronic cigarette cartridges are available. Many vapers are using such products, or trying to wean themselves down to nicotine-free cartridges, and the surprising finding is that even without the nicotine, e-cigarettes are a viable alternative for many smokers.

Now, as far as the argument that people who quit smoking and start vaping are people who would otherwise quit using nicotine completely, there is simply no evidence to support such a position. There is, however, vast evidence that the people who are choosing to switch to e-cigarettes are people who feel that they cannot quit smoking and so they welcome the alternative that vaping provides. These are largely individuals who have already tried to quit - unsuccessfully. Thus, they are not people who would quit smoking were only e-cigarettes banned. They are people who would return to their Marlboros if e-cigarettes were banned.

Finally, the argument that e-cigarettes appeal to children and are being marketed as such is merely a hypothetical one, for which there is - again - no evidence. The product is clearly being marketed for use by existing smokers. Moreover, there is no evidence that any kids are using the product. At $80 to $120 a pop, it is difficult to argue that e-cigarettes are being marketed to children.

If Kentucky is concerned about kids starting to vape, then it is certainly reasonable for the state to enact a law prohibiting the sale of e-cigarettes to minors. But to ban e-cigarettes completely because of this concern makes absolutely no sense. Why create thousands of new smokers in Kentucky overnight? Why add to the already high burden of tobacco-related disease and death in the Bluegrass state?

Once again, it appears that the abstinence only mentality - with its ideological rather than science- or health-based underpinnings - is getting in the way of protection of the public's health. We went down the wrong road for so long with abstinence-only education, limitations on needle exchange programs, and restrictions on methadone maintenance programs. It's a shame to see tobacco control headed down that same road.

Wednesday, September 09, 2009

According to an article in the Birmingham News, a physician who opposes use of the electronic cigarette argues that because e-cigarettes make you feel like you're still smoking, these devices do not help get rid of the cigarette smoking habit. He also argues that youths will be attracted to electronic cigarettes because the cartridges contain chocolate.

According to the article: "Besides the potentially toxic nature of the devices, those using them as a smoking cessation device might not really get off cigarettes, one Birmingham doctor says. Dr. William Bailey, medical director of the UAB Lung Health Center, said there are many smoking cessation devices, including patches and gum, but there have been no studies to back up claims that electronic cigarettes help. And he has his doubts they do. By mimicking the action of smoking while still delivering nicotine and other chemicals to the body, the e-cigarettes don't help get rid of the habit. It's designed to make you feel like you're still smoking, he said. 'I think it's more harmful than helpful ... and likely to increase nicotine addiction and cigarette consumption,' Bailey said."

"Michael Siegel, professor of community health sciences at Boston University's School of Public Health, said he believes the product could be a good smoking cessation device. Also, Siegel said, e-cigarette users aren't inhaling potentially thousands of harmful chemicals into their bodies, as they do with tobacco. 'From a public health standpoint these devices are potentially life saving,' he said."

"Some health officials also are concerned that e-cigarette companies may be marketing toward kids because many of the brands have cartridges in flavors such as strawberry and chocolate. 'Who's going to want a chocolate cigarette but a kid?' Bailey said."

The Rest of the Story

This physician's comments make no sense. "By mimicking the action of smoking while still delivering nicotine and other chemicals to the body, the e-cigarettes don't help get rid of the habit. It's designed to make you feel like you're still smoking." Well, that's exactly the point. The reason why these devices have apparently been so effective in helping smokers to quit is that they simulate smoking.

The point is: e-cigarettes do help get rid of the smoking habit. What this physician doesn't seem to realize is that if you are using electronic cigarettes exclusively, then you're not using the real ones. In other words, you are an ex-smoker. You have quit smoking successfully. You have gotten rid of the habit.

It appears that this physician has fallen into the trap that many anti-smoking groups have fallen into: caring only about the act of "smoking," not about the actual health effects of a person's behavior.

The physician goes on to argue that using e-cigarettes is more harmful than helpful. How could a product which delivers nicotine be more harmful than one which delivers nicotine plus thousands of other chemicals? Moreover, he goes on to argue that using e-cigarettes will increase cigarette consumption. That is virtually impossible, because every e-cigarette consumed by a smoker is one less cigarette consumed by that smoker. While vaping does not always result in a smoker quitting completely, it by definition results in a smoker cutting down on his or her cigarette consumption.

The final assertion made by this physician - that youths are going to want a chocolate cigarette - shows a complete lack of understanding of the appeal of smoking to adolescents. The appeal of smoking is precisely that it is viewed as an adult behavior. Teenagers don't smoke chocolate cigarettes, they smoke Marlboros, Newports and Camels. And they do this because they want to look and feel like adults. Cigarettes are viewed as a sign of maturity, not as a sign of being a kid. They are smoking precisely to escape the label of being a kid and to feel more adult-like, independent, and mature. Smoking a chocolate cigarette is actually the last thing in the world a teenager would want to be seen doing.

What is so disturbing about this physician's public statements is not that he opposes e-cigarette use, but that his opinions are based on such a complete misunderstanding of the health issues related to both smoking and e-cigarette use.

I would also argue that his opinions are damaging to the public's health because he is actually encouraging smokers to continue smoking rather than to quit using e-cigarettes. And worse, he is essentially encouraging ex-smokers who use e-cigarettes to return to cigarette smoking. The reality is that in advising ex-smokers not to continue vaping, he is giving them no option but to return to smoking, because the overwhelming majority of these vapers are not going to quit smoking entirely. Vapers know that the removal of e-cigarettes as an option is almost certainly going to force them to go back to the real thing, and that is why they are so scared about the threats by the FDA to remove this product from the market. Their health and lives are at stake, and apparently, physicians like the one quoted in this article would rather that these vapers be forced to return to cigarette smoking than that they remain ex-smokers who use a device that makes them feel like they are still smoking.

Publicly giving advice that is going to harm many smokers is bad enough, but doing so based on complete misinformation is extremely unfortunate.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.